PastDrugHistory_DrugName

Name of a drug previously taken but not used concomitantly and not potentially involved in the adverse event.

Case Form / Patient / Other Relevant History / Description

PastDrugHistory_StartDate Time

Date when the previously taken drug was started.

Case Form / Patient / Other Relevant History / Start Date

PastDrugHistory_EndDate Time

Date when the last dose of the previously taken drug was given.

Case Form / Patient / Other Relevant History / Stop Date

PastDrugHistory_Drug Indication

Reason for taking the previously taken drug. Map to the user-entered verbatim or to the encoded MedDRA lower-level term.

Case Form / Patient / Other Relevant History / Indication

PastDrugHistory_Indication MedDRAVersion

Version of MedDRA used to code the indication if the indication is mapped to a lower-level term.

For items to be encoded in Argus Safety, MedDRA version is required by the format used for transmitting data but does not appear in Argus Safety.

PastDrugHistory_Drug Reaction

Adverse event experienced when taking the previously taken drug. Map to the user-entered verbatim or to the encoded MedDRA lower-level term).

Case Form / Patient / Other Relevant History / Reaction

PastDrugHistory_Reaction MedDRAVersion

Version of MedDRA used to code the indication if the indication is mapped to a lower-level term.

Note: If reaction is mapped to a text field entered by the user, do not map this field.

For items to be encoded in Argus Safety, MedDRA version is required by the format used for transmitting data but does not appear in the Argus Safety.